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FDA 510(k)

i-STAT PTplus Cartridge with the i-STAT 1 System

K-Number: K220282 · 2023-07-14

ApplicantAbbott Laboratories
Decision Date2023-07-14
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

i-STAT PTplus Cartridge with the i-STAT 1 System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K220282. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-STAT PTplus Cartridge with the i-STAT 1 System?

i-STAT PTplus Cartridge with the i-STAT 1 System is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Abbott Laboratories. The 510(k) number is K220282.

When did i-STAT PTplus Cartridge with the i-STAT 1 System receive FDA 510(k) clearance?

i-STAT PTplus Cartridge with the i-STAT 1 System received FDA 510(k) clearance on 2023-07-14, under 510(k) number K220282.

Who is the listed applicant for i-STAT PTplus Cartridge with the i-STAT 1 System?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-STAT PTplus Cartridge with the i-STAT 1 System?

The FDA product code for i-STAT PTplus Cartridge with the i-STAT 1 System is GJS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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